MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 2, 9MM, SLOPE +; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	200-62-09
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Erosion (1750); Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, on (b)(6) 2009, patient underwent a bilateral total knee replacement surgery and was implanted with an optetrak polyethylene tibial insert.On (b)(6) 2021, approximately 12 years 2 months after their initial replacement, they underwent left knee revision surgery, which included the removal of the failed polyethylene liner, due to accelerated and preventable wear of the optetrak polyethylene tibial insert.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: 1229208, 200-02-29 - three peg patella 29mm; 1378603,200-02-29 - three peg patella 29mm; 8175499,202-01-02 - cr porous femoral rep by 232-(02-03)-02; 8354015,202-01-02 - cr porous femoral rep by 232-(02-03)-02; 86005,203-96-21 - (11-2714) stryker 2000 90x13/21x 1.9mm; 89080,203-96-21 - (11-2714) stryker 2000 90x13/21x 1.9mm; 1281525,204-04-21 - trapezoid tibial tray sz 1f/1t, 2f/1t; 1323939,204-04-21 - trapezoid tibial tray sz 1f/1t, 2f/1t.
Additional Manufacturer Narrative
H6: investigation results - the revision reported may have been the result of polyethylene wear and loosening as stated in the legal documentation and operative notes.The loosening may have been the result of an insufficient bond between the implants and the bones.The extent and root cause of the reported polyethylene wear cannot be determined as the devices were not available for evaluation, and radiographs and photographs were not provided.
Event or Problem Description
Report #1 of 4 for this event.As reported this patient had initial bilateral total knee arthroplasty.Subsequently, twelve (12) years, two (2) months later the patient underwent a revision of the left knee due to loose prosthesis.A revision operative report was provided.Intraoperatively, it was noted the femoral, tibial tray and patella components were loose.The patient was revised to another manufacturer's construct.The patient was awakened and taken to the recovery room in satisfactory condition.Additionally, it was reported via legal documentation, the patient had a revision procedure due to early prosthesis wear of the polyethylene tibial insert component.And as a direct, proximate, and legal consequence of the defective nature of the device, the patient suffered and continues to suffer injures and damages, including but not limited to, significant pain and discomfort; gait impairment; poor balance; difficulty walking; component part loosening; soft tissue damage; bone loss; and other injuries presently undiagnosed.No further information is available.

• Brand Name: CR TIBIAL INSERT SZ 2, 9MM, SLOPE +
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523782617
• MDR Report Key: 16888868
• Report Number: 1038671-2023-00931
• Device Sequence Number: 6312342
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/25/2013
• Device Model Number: 200-62-09
• Device Catalogue Number: 200-62-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 08/14/2023; 09/21/2026
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 08/18/2023; 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female